FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,053 results
15361–15384 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 12, 1984
FLUSH DEVICE
K833170 · DRS
Transamerica Delaval, Inc.
Cardiovascular · 331d
Cleared Aug 12, 1984
NOVA BALLOON THERMODILUTION CATH.
K841639 · DYG
Nova Medical Specialties
Cardiovascular · 114d
Cleared Aug 12, 1984
NOVA BALLOON THERMODILUTION INFUSION
K841640 · DYG
Nova Medical Specialties
Cardiovascular · 114d
Cleared Aug 10, 1984
PERIPHERAL DILATATION ANGIOPLASTY-CATH
K834429 · LIT
American Edwards Laboratories
Cardiovascular · 239d
Cleared Aug 10, 1984
COMPUTER, CENTRAL PROCESSING UNIT
K841261 · DXG
Nem Computer Corp.
Cardiovascular · 137d
Cleared Aug 10, 1984
MULTIPRO CATHETER
K841797 · DQY
Shiley, Inc.
Cardiovascular · 109d
Cleared Aug 10, 1984
SARNS EVACUPLEGE CATHETER
K842044 · DWE
3M Health Care, Sarns
Cardiovascular · 81d
Cleared Aug 10, 1984
VENOUS CANNULA W/BENT, TIP WIRE
K842375 · DWF
Dlp, Inc.
Cardiovascular · 53d
Cleared Aug 10, 1984
GAMBRO PULSATILE MONITOR PLM 10-200
K842503 · DWA
Gambro, Inc.
Cardiovascular · 45d
Cleared Aug 10, 1984
ADVANCED CARDIOVASCULAR BALLOON DILATA
K842556 · LIT
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 39d
Cleared Aug 10, 1984
SHILEY CARDIOTOMY RESERVOIR W/FILTER
K842711 · DTN
Shiley, Inc.
Cardiovascular · 29d
Cleared Aug 10, 1984
INTRAOPERATIVE ANGIOSCOPE DELIVERY CATH
K842798 · DQO
American Edwards Laboratories
Cardiovascular · 24d
Cleared Aug 10, 1984
PERCUTANEOUS ANGIOSCOPE DELIVERY CATH
K842799 · DQO
American Edwards Laboratories
Cardiovascular · 24d
Cleared Aug 08, 1984
BIOLAS YAG 100
K842670
Advanced Biomedical Instruments
Cardiovascular · 29d
Cleared Aug 06, 1984
NEOS LP
K841633 · DXY
Biotronik Sales, Inc.
Cardiovascular · 109d
Cleared Aug 06, 1984
DESERET DISPOSABLE PRESSURE TRANSDUCER
K841968 · DRS
Parke-Davis Co.
Cardiovascular · 83d
Cleared Aug 03, 1984
PALL EC PLUS FILTER
K834380 · DTM
Pall Biomedical Products Co.
Cardiovascular · 233d
Cleared Aug 03, 1984
PALL EC PLUS FILTER W/FILTER SLEEVE
K834382 · DTM
Pall Biomedical Products Co.
Cardiovascular · 233d
Cleared Aug 03, 1984
ARTERIAL EMBOLECTOMY CATHETER
K840198 · DXE
Shiley, Inc.
Cardiovascular · 198d
Cleared Aug 03, 1984
ELECTROCARDIOGRAPH E-340
K840440 · DPS
Burdick Corp.
Cardiovascular · 184d
Cleared Aug 03, 1984
LITHIUM PACEMAKER 811-811L & 811XL
K840748 · DXY
Omikron Scientific, Ltd.
Cardiovascular · 162d
Cleared Aug 03, 1984
TUBULAR HOLLOW FIBER MEMBRANE
K841476 · DTZ
American Bentley
Cardiovascular · 116d
Cleared Aug 03, 1984
SCANLAN ENDARSECTOR
K841521 · DWX
Scanlan Intl., Inc.
Cardiovascular · 113d
Cleared Aug 03, 1984
LEPTOS
K841635 · DXY
Biotronik Sales, Inc.
Cardiovascular · 106d